Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

Efficacy and Safety of Intra-articular Multiple Doses of 500 µg Icatibant Including 40 mg Triamcinolone as Calibrator in a Randomized, Double-blind, Parallel-group, Placebo-controlled 13-week Multi-centre Study in Patients With Symptomatic Knee Osteoarthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00303056

Enrollment

590

Registered

2006-03-15

Start date

2006-02-28

Completion date

2007-07-31

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Disease

Keywords

Osteoarthritis, knee

Brief summary

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

Detailed description

This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Interventions

DRUGHOE140 Icatibant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female subjects with painful osteoarthritis of the knee.

Exclusion criteria

* Subjects presenting with diagnosis of OA \< 3 months and an OA grading \< K&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the CSP).

Design outcomes

Primary

Measure	Time frame
Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS).	—

Secondary

Measure	Time frame
Patient global assessment assessed daily as well as WOMAC scores at each visit and intake of rescue medication daily via EPD recording. Safety assessed at each visit and pharmacokinetics at visits 2, 3 & 4.	—

Countries

Austria, Czechia, Germany, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026